Novocol OraVerse Injection Recall: Cracked Cartridges Risk

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Contact the company & request your remedy

Recalling firmNovocol Pharmaceutical of Canada, Inc.25 Wolseley Crt · Cambridge, N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Novocol is recalling OraVerse injections because the cartridges can crack, potentially causing leakage. This could lead to improper medication use or injury if the product leaks. The recall affects prescription-only units sold in Canada.

Why it’s dangerous

Cracked cartridges can leak medication, which may cause improper dosing or accidental exposure. This defect occurs during manufacturing and can happen in normal use conditions.

Who’s affected

Prescription users of OraVerse injections in Canada. Those with the specific lot number D05004E are most at risk.

How to tell if you have this one

Check for OraVerse injections with 10 cartridges, 0.4 mg/1.7mL, lot number D05004E, expiring 04/30/2027. The product is prescription-only and distributed by Septodont, Inc. in Canada.

Brand
Novocol
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Cartridge Integrity
Inspect each cartridge for cracks or breaks before use.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product is safe if cartridges are intact. Cracked cartridges may leak, so check each cartridge before use.

What should I do if I have a cracked cartridge?

Discard the cartridge and contact your healthcare provider for a replacement.

How can I tell if I have the recalled product?

Look for OraVerse injections with 10 cartridges, 0.4 mg/1.7mL, lot D05004E, expiring 04/30/2027.

Take action

Contact Novocol

We’ve drafted a message you can send Novocol to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0234-2026 — Novocol Novocol

Hello,

I own a Novocol that is covered by recall D-0234-2026 from Novocol.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0234-2026 (October 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0234-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Novocol Pharmaceutical of Canada, Inc. recalls OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,

Lower-risk recall